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Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AcrySof Toric intraocular lens, model SN60TT
AcrySof Monofocal IOL, model SN60AT
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Corneal astigmatism, Intraocular lens

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral cataract
  • Bilateral corneal astigmatism (at least 1.25D)
  • Predicted residual astigmatism less than 0.5D

Exclusion Criteria:

  • Irregular corneal astigmatism or keratoconus
  • Fuchs endothelial dystrophy (stage 2)
  • Expected postoperative best-corrected visual acuity worse than logMAR +0.3

Sites / Locations

  • Atrium Medical Center
  • Maastricht University Medical Center
  • Rotterdam Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Toric intraocular lens

Monofocal intraocular lens

Arm Description

Bilateral Toric intraocular lens implantation in cataract surgery

Bilateral Monofocal intraocular lens implantation in cataract surgery

Outcomes

Primary Outcome Measures

Spectacle independency
Spectacle independency for distance vision

Secondary Outcome Measures

Visual acuity
Refractive astigmatism
Higher-order wavefront aberrations
Contrast sensitivity
Costs related to intervention
Total cost-analysis, including out-of-hospital costs for patient
Quality of vision
Refractive-error related quality of vision

Full Information

First Posted
February 24, 2010
Last Updated
January 13, 2014
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01075542
Brief Title
Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens
Official Title
Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.
Detailed Description
A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision. Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness. Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery. Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Corneal astigmatism, Intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toric intraocular lens
Arm Type
Experimental
Arm Description
Bilateral Toric intraocular lens implantation in cataract surgery
Arm Title
Monofocal intraocular lens
Arm Type
Other
Arm Description
Bilateral Monofocal intraocular lens implantation in cataract surgery
Intervention Type
Device
Intervention Name(s)
AcrySof Toric intraocular lens, model SN60TT
Intervention Description
The lens is made of foldable acrylic material and is implanted in the capsular bag
Intervention Type
Device
Intervention Name(s)
AcrySof Monofocal IOL, model SN60AT
Intervention Description
The lens is made of foldable acrylic material and is implanted in the capsular bag
Primary Outcome Measure Information:
Title
Spectacle independency
Description
Spectacle independency for distance vision
Time Frame
preop, 3 months and 6 months postop
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
preop, 1 day, 1 month, 3 months and 6 months postop
Title
Refractive astigmatism
Time Frame
preop, 3 months and 6 months postop
Title
Higher-order wavefront aberrations
Time Frame
preop, 3 months and 6 months postop
Title
Contrast sensitivity
Time Frame
preop, 3 months and 6 months postop
Title
Costs related to intervention
Description
Total cost-analysis, including out-of-hospital costs for patient
Time Frame
preop, 3 and 6 months postop
Title
Quality of vision
Description
Refractive-error related quality of vision
Time Frame
preop, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral cataract Bilateral corneal astigmatism (at least 1.25D) Predicted residual astigmatism less than 0.5D Exclusion Criteria: Irregular corneal astigmatism or keratoconus Fuchs endothelial dystrophy (stage 2) Expected postoperative best-corrected visual acuity worse than logMAR +0.3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudy Nuijts, MD, PhD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Medical Center
City
Heerlen, Brunssum, Kerkrade
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Rotterdam Eye Hospital
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18721707
Citation
Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
Results Reference
background
PubMed Identifier
25256624
Citation
Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.
Results Reference
derived

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Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

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